Weekly intravenous infusion on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of AUY922 is 40, 55, and 70 mg/m2 will be used.

Drug: Cetuximab

Cetuximab will be administered after each AUY922 infusion, intravenously on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed colorectal cancer

KRAS wild type metastatic colorectal cancer

Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan

Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities

Must have at least one measurable lesion

Must be 18 years of age or older

ECOG performance status 0-1

Life expectancy must be greater than 12 weeks

For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion

Exclusion Criteria:

Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown

Metastasis to the CNS

Prior treatment with any Hsp90 inhibitor compounds

Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:

Radiotherapy, conventional chemotherapy: within 2 weeks

Palliative radiotherapy: within 2 weeks

Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks

Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)

Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]

Known sensitivity to cetuximab

Unresolved ≥ grade 1 diarrhea

Malignant ascites that require invasive treatment

Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis

Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy

Impaired cardiac function

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294826